THE FOLLOWING TWO stories should be read together. The first is from the New York Times, the second is based on a press release from the Ukiah Valley Medical Center:
MENINGITIS OUTBREAK, NYT October 4th 2012. By Denise Grady, Sabrina Tavernise and Andrew Pollack.
The nation’s growing outbreak of meningitis, linked to spinal injections for back pain, was a calamity waiting to happen — the result of a lightly regulated type of drug production that had a troubled past colliding with a popular treatment used by millions of Americans a year. The outbreak, with five people dead and 30 ill in six states, is thought to have been caused by a steroid drug contaminated by a fungus. The steroid solution was not made by a major drug company, but was concocted by a pharmacy in Framingham, Mass., called the New England Compounding Center. Compounding pharmacies make their own drug products, which are not approved by the Food and Drug Administration. On Monday, federal inspectors at the New England center found a sealed vial of the steroid afloat with so much foreign matter that it could be seen with the naked eye, Food and Drug Administration officials said Thursday. Under the microscope, the particles were a fungus. The drug has been recalled, the clinics that used it are scrambling to warn patients who might have been exposed and health officials are urging anyone feeling ill after a spinal steroid injection to contact a doctor quickly, especially for symptoms like severe headache, fever, nausea, dizziness, loss of balance or slurred speech. They are also urging doctors and hospitals to stop using any products made by the New England Compounding Center. The pharmacy had shipped 17,676 vials of this potentially contaminated solution to 75 clinics in 23 states, according to Massachusetts and federal health officials. The question is, Why? Why would pain clinics around the country rely on a pharmacy that mixes its own brand of unapproved drugs, especially for a delicate procedure like an epidural injection that has the potential — realized in these awful cases — to infect a patient’s nervous system? There seems to be no one answer. Some doctors say compounding pharmacies offer specialty products or dosages not easily found elsewhere, or sometimes simply better prices than big drug companies. But other physicians have reservations about using compounded pharmaceuticals. Dr. Arthur S. Watanabe, an interventional pain specialist in Spokane, Wash., said the steroid for spinal injection was available from mainstream drug companies, and he could not understand why anyone would buy it from a compounding pharmacy. Compounding has been called an ancient art, something practiced long before medicines were premixed and sealed in bubble packs. The practice goes on today, allowed by states and the federal government, but it is supposed to provide custom-made products for individual patients with special needs. It is frequently done in hospital pharmacies, and an estimated 2 to 3 percent of prescriptions in the United States are compounded prescriptions for individual patients, according to the International Academy of Compounding Pharmacists. Pharmacies and regulators have struggled for years over what limits to set on the practice. Compounding has fallen between state and federal authorities, and the legal status of compounded drugs has never been clear. Compounding is tolerated by the FDA, as long as the pharmacy does not ship across state lines, mass produce drugs or use commercial scale equipment, said James H. Ruble, an assistant professor at the University of Utah College of Pharmacy. But recent court cases, including one in federal court in Florida, have raised questions about the FDA’s authority. In a case involving a compound-maker called Franck’s that was producing compounds for veterinary use, a judge ruled that the FDA could not assume it had authority to regulate compounding pharmacies, Professor Ruble said. That case is on appeal. Health officials worry about compounding because it has its risks. The pharmacies are not held to the same safety standards as big drug companies. The current outbreak is not the first time a steroid made by this type of pharmacy has caused fungal meningitis in people receiving spinal steroid injections. There were five similar cases, including a death, in 2002, all traced to one pharmacy in South Carolina that had been shipping its product to five states. Inspectors found contaminated vials and a complete lack of quality controls or sterility testing at the pharmacy. In 2011, nine patients at an Alabama hospital died after receiving a feeding solution contaminated with bacteria, which had been prepared by a compounding pharmacy in Birmingham. The New England center has had a long history of problems. Dr. Madeleine Biondolillo, director of the Bureau of Health Care Safety and Quality at the Massachusetts Department of Public Health, said there had been three complaints registered against it, in 2002, 2003, and this year in March, when the potency of a compound used in eye surgery was questioned. Its ability to perform sterile processing was also questioned. State officials said it made dozens of medications, both injectable and noninjectable medicines as well as topical creams. Officials said the center was starting with a powdered drug and mixing it with liquid to make a solution of the steroid methylprednisolone acetate that was ultimately used for spinal steroid injections. But special care is needed in making drugs to be injected into the spine because of the seriousness of infections there, said Charles Leiter, the president of Leiter’s Compounding Pharmacy in San Jose, Calif. “I try and stay away from drugs for the spinal column because if you make a mistake, they are dead,” Mr. Leiter said. He added, “Taking a suspension and sterilizing it for use in the spinal column is very tricky.” The New England center had also received warnings in the past from the F.D.A., though not about its steroid drugs. The earlier warnings had cautioned it against opening sterile vials of a cancer drug, Avastin, and repackaging the drug in smaller doses to be used to treat an eye disease. The agency had also warned the center against selling a pain cream that contained a powerful mixture of local anesthetics and that could be toxic and even cause heart problems if too much was rubbed into the skin. Joe Cabaleiro, executive director of the Pharmacy Compounding Accreditation Board, said that the New England center had never applied for accreditation as meeting the industry’s quality standards — a voluntary move that only 162 out of about 3,000 compounding pharmacies have done so far.
UKIAH VALLEY MEDICAL CENTER WARNING — A drug called preservative-free methylprednisolone acetate, used as a pain medication with some patients seen by Dr. Michael Young, the UVMC pain specialist, may cause meningitis. The hospital's letter reads, “A group of patients at an ambulatory center in Tennessee received an epidural injection similar to the one that you received... at the (Ukiah) Pavilion Surgical Services. We were notified that the patients in Tennessee developed some symptoms similar to meningitis. The New England Compound Center which manufactured this lot of steroids has recalled this particular compound across the nation as a precautionary measure. If for some reason you happen to experience any unusual symptoms within one to four weeks following your treatment, please seek the appropriate level of care: emergencies should always go to the closest emergency department, and non-emergencies should contact your physician's office during normal business hours. Although we don't anticipate any reactions to the injections, there are some symptoms you should be aware of: a stiffening of the neck or a different kind of headache than you've previously experienced, fever, stiffness, sensitivity to light or stroke-like symptoms (localized weakness, numbness or slurred speech).”
THE LETTER is signed by Heather Van Housen, RN, MSN, the hospital's patient care executive. She adds, “Our team will be closely monitoring the activities related to this recall and will notify you of changes that would require additional attention.”
ANOTHER LETTER is going out to patients who received the drug some time ago: “If you were in any danger, you would most likely have already developed meningitis-type symptoms or experienced a different type of pain than your original symptoms.” It suggests patients call Dr. Young if they have questions, but to go immediately to the emergency room if they have symptoms.
THE HOSPITAL said it made the letters public to make sure patients who may have received the drug are aware of the recall.
LATE FRIDAY the Hospital issued the following Press Release:
“No Recall Related Reports of Meningitis — Ukiah, CA— Even after a national recall and meningitis scare there have been no reported cases in Mendocino County, according to Heather Van Housen, patient care executive at Ukiah Valley Medical Center. This was in response to the voluntary medication recall initiated by the manufacturer, the New England Compound Center. The medication was administered during a procedure at the Outpatient Pavilion at Ukiah Valley Medical Center. According to the Centers for Disease Control (CDC) there are currently no reported cases of meningitis related to the medication recall in California. The CDC urges those who have questions about the recall to call their information hotline at 1-800-232-4636.”
THE UKIAH POLICE DEPARTMENT is investigating the suspicious death of Duane Johnson, 45, of Ukiah, who was found unconscious and not breathing in the 300 block of North Main Street at 5:42am, September 4th. Johnson could not be resuscitated and died at the Ukiah Valley Medical Center. The Ukiah Fire Department was told that Johnson had fallen. However, Ukiah Police Department detectives determined that Johnson had not died from a fall but was a “victim of foul play.” Manuel Rodriguez, 21, has been identified as a suspect in Johnson's death and the public's help is being sought to locate him. Dewey said Rodriguez is believed to have fled to Mexico. He is described as 5-9, 220-pounds, with black hair and brown eyes. He was last known to be traveling with his girlfriend and her 2-year-old son. The Ukiah PD says Rodriguez is a “documented gang member from Sonoma County” with a history of violence. Anyone with information about the case or Rodriguez's whereabouts is asked to contact the UPD at 463-6262.
IN YESTERDAY’s PRESS DEMOCRAT STORY, we find these two laugh lines: “Evans did not return several messages seeking comment this week. Her staff said she was traveling in Russia and France on state business.” Really? What business would that be for a Northcoast state senator?
GAS PRICES in California have spiked in recent weeks and are now running about $4.50 a gallon in San Francisco, according to the Motor Trend gas price website, although prices there vary somewhat. In Mendocino County gas prices (for regular) range from about $4.10 in a few places to nearly $5.00 in some of the more remote areas like Boonville or Philo. The average price of regular gas across the state was nearly $4.49 a gallon, the highest in the nation, according to AAA's Daily Fuel Gauge Report. In many areas of California, prices have jumped 40¢ in a week as wholesale prices soared. Some stations in Southern California ran out of gas and shut down Thursday rather than pay the extra wholesale costs. The national average for gas is about $3.79 a gallon, the highest ever for this time of year when prices historically decline. Gasoline inventories in California are reported to be the lowest in more than 10 years which the usual oil industry analysts attribute to California’s “special blend” environmental requirements on top of recent refinery problems, particularly Chevron’s Richmond refinery fire in August. But it’s hard to believe that long-standing regulations, costly as they may be, or even the two-month old refinery problems are the cause for this latest price spike in just a few days. There are probably other reasons in the mix having to do with the usual market “speculation” that the industry analysts seldom mention. Nevertheless the situation is not expected to improve any time soon. Patrick DeHaan, senior petroleum analyst at GasBuddy.com, said California prices will keep rising because in the past week wholesale gasoline prices have jumped $1 a gallon, but average retail prices have increased only 30¢. Some analysts think prices nationally will start coming down for the winter, but they think California could see a longer spike given its “unique fuel requirements.”
LOST IN LOST IN TRANSLATION TRANSLATION. An Iranian news agency apologized for touting a story written by spoof newspaper The Onion last week that said most white Americans would vote for Mahmoud Ahmadinejad over Barack Obama. The English-language version of Fars, the semiofficial mouthpiece of Iran's Revolutionary Guard, ran the article, headlined, “Gallup Poll: Rural Whites Prefer Ahmadinejad to Obama,” nearly word-for-word on Friday. The joke piece said 77% of “rural Caucasian voters” preferred the Iranian president to Obama and quoted a fake West Virginia resident saying, “He takes national defense seriously, and he'd never let some gay protesters tell him how to run his country like Obama does.” The “responders” in the outlandish Onion story also said they'd rather have a beer or go to a baseball game with the Iranian dictator and liked the fact that Ahmadinejad “doesn't try to hide the fact that he's Muslim.” But a description of the Iranian president as “a man who has repeatedly denied the Holocaust and has had numerous political prisoners executed” was left out. Red-faced Fars officials apologized in a statement on its website on Monday, but couldn't resist taking potshots at other media companies for a few “embarrassing blunders” of their own. “All media, at least those you know like the BBC, CNN, etc., have had many goofs,” the statement said, citing gaffes it said were made in the New York Times, London's The Telegraph and other news agencies. In fact, The Times was burned by The Onion last year when it published a story about Tiger Beat magazine along with a photo of Obama on the magazine’s cover. The cover was actually from an Onion story. Though The Onion poll story was a fake, the Iranian news organ said it could have been true. “Although it does not justify our mistake, we do believe that if a free opinion poll is conducted in the US, a majority of Americans would prefer anyone outside the US political system to President Barack Obama and American statesmen,” Fars unnamed editor-in-chief was quoted as saying. (Courtesy, the NY Daily News)